Principal Validation Engineer

Curia • Albuquerque, NM

4d

About The Position

The Principal Validation Engineer serves as the senior Validation Subject Matter Expert (SME) on the New Product Introduction (NPI) Tech Transfer Team, providing strategic technical leadership for complex technology transfer and commercialization programs in a sterile pharmaceutical manufacturing environment. The role develops and implements validation strategies, supports operational readiness, and oversees qualification and lifecycle validation activities needed to introduce new products and technologies into the facility. It works across Program Management, Manufacturing, Technical Operations, Quality, Regulatory Affairs, Engineering, Microbiology, Analytical Sciences, and customer teams. The position is the senior Validation representative for multiple concurrent NPI programs and provides customer-facing technical leadership from project initiation through commercial launch.

The role requires advanced expertise in process validation, cleaning validation, equipment and utility qualification, computerized systems validation, sterilization validation, aseptic process validation, facility qualification, and lifecycle validation. It supports technology transfer, engineering studies, process performance qualification (PPQ), and commercial manufacturing while ensuring compliance with applicable regulatory and quality requirements. The position has no supervisory responsibilities, but may mentor, guide, and advise others.

The role is based in Albuquerque, New Mexico. Curia describes itself as a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments.

Requirements

• Bachelor’s degree in Science, Engineering, or a related technical discipline and at least 12 years of validation, technology transfer, manufacturing science, or process engineering experience in sterile pharmaceutical manufacturing; alternatively, a Master’s degree in one of these fields and at least 10 years of such experience.
• Advanced expertise in process validation, cleaning validation, equipment qualification, utility qualification, computerized systems validation, sterilization validation, aseptic process validation, and lifecycle validation principles in sterile pharmaceutical manufacturing.
• Strong technical writing skills to author validation documentation.
• Excellent verbal and written communication skills.
• Ability to work semi-independently and interact effectively with other technical departments.
• Excellent presentation and influencing skills, including the ability to gain senior management support.
• Leadership and collaboration skills in cross-functional, fast-paced environments.
• Ability to organize time and manage multiple projects and priorities.
• Ability to read, understand, interpret, and implement technical writing and instructions.
• Effective interpersonal skills and adaptability to achieve company goals.
• Strong attention to detail.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening and obtain and maintain gowning certification, media qualification, and respirator use.

Nice To Haves

• New Product Introduction (NPI) and technology transfer experience.
• Process validation and cleaning validation program leadership.
• Experience supporting PPQ campaigns and commercial product launches.
• Experience with aseptic processing, sterilization validation, facility qualification, and critical utility qualification.
• Experience interacting with customers and regulatory agencies.
• Working knowledge of FDA and EU GMP requirements, Annex 1, Annex 11, PIC/S, ISPE, PDA, and GAMP principles.
• Ability to provide guidance and mentorship, foster a collaborative and positive work environment, and champion change.

Responsibilities

• Serve as the senior Validation SME for assigned NPI and technology transfer programs.
• Provide strategic technical leadership for validation activities supporting new product introductions and commercial launches.
• Participate as a core member of cross-functional Tech Transfer Teams from project initiation through commercial launch.
• Lead validation assessments, fit-gap analyses, risk assessments, and operational readiness reviews.
• Develop validation strategies to support technology transfer, process implementation, and commercialization.
• Provide technical leadership during customer meetings, technical discussions, audits, and governance reviews.
• Partner with Program Managers to identify project risks, mitigation strategies, resource requirements, and critical-path activities.
• Drive operational readiness for engineering studies, demonstration batches, PPQ campaigns, and commercial manufacturing.
• Support knowledge transfer between sending and receiving organizations.
• Participate in Technical Review Boards, change management reviews, and stage-gate governance activities.
• Provide technical leadership for process validation, equipment qualification, utility qualification, sterilization validation, computerized systems validation, cleaning validation, facility qualification, and aseptic process validation.
• Develop and approve validation strategies, validation master plans, risk assessments, protocols, reports, and lifecycle validation documentation.
• Evaluate manufacturing processes and technology-transfer documentation to determine validation requirements, critical process parameters, critical quality attributes, and acceptance criteria.
• Lead complex technical investigations and provide expert guidance for validation-related deviations, change controls, and CAPAs.
• Establish and maintain validation standards, practices, and governance frameworks supporting commercialization.
• Review and approve validation documentation for scientific soundness, regulatory compliance, and alignment with customer requirements.
• Support implementation of new technologies, equipment, manufacturing processes, and digital systems from a validation perspective.
• Ensure validation activities comply with regulatory expectations, industry standards, site procedures, and customer commitments.
• Serve as validation SME during regulatory inspections, customer audits, and technical due diligence.
• Support responses to validation-related observations, commitments, and regulatory inquiries.
• Maintain current knowledge of global regulatory expectations, industry guidance, and validation best practices.
• Mentor and provide technical guidance to validation engineers and cross-functional project teams.
• Promote standardization and continuous improvement of validation and technology-transfer processes, tools, and templates.
• Collaborate with cross-functional teams to resolve complex technical challenges.
• Develop and deliver training on validation strategy, technology transfer, and operational readiness.
• Read and interpret SOPs and regulatory requirements to ensure compliance.
• Maintain required training qualifications.
• Perform other duties as assigned.
• Promote a safe and healthy work environment by identifying potential hazards, following safety protocols, participating in safety training, and fostering awareness and responsibility.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior